What is Intelence used for?

HIV infection. Intelence must be used in combination with other anti-HIV medicines.

How does Intelence work?

Intelence tablets contain the active ingredient etravirine, which is a type of medicine called a non-nucleoside reverse transcriptase inhibitor. It is used in the treatment of HIV (human immunodeficiency virus) infection.

AIDS (acquired immune deficiency syndrome) is caused by infection with HIV. This virus invades cells of the immune system, particularly the white blood cells known as CD4 T-helper lymphocytes. These cells normally work to activate other cells in the immune system to fight infection. Since HIV kills CD4 T-helper cells, over time the body becomes less able to fight the virus or subsequent infections.

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Once the virus is inside the CD4 T-cell it multiplies. Part of the process of viral multiplication involves the conversion of the virus genetic material, RNA, into DNA. This is achieved by a compound essential to the virus, called reverse transcriptase. Reverse transcriptase is a compound known as an enzyme. Etravirine works by blocking the action of this enzyme, thereby interfering with the conversion of viral RNA into DNA. This stops the virus from multiplying.

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There is no cure for HIV, but etravirine is among several medicines that lower the amount of virus in the body (viral load), help the immune system to recover, and therefore slow down or stop the progression of the disease from HIV to AIDS.

A combination of several anti-HIV medicines is required to fight HIV because the virus can become resistant to one agent very quickly. This is known as combined antiretroviral therapy (cART) or highly active antiretroviral therapy (HAART). Etravirine is used in combination with other anti-HIV drugs that attack the HIV virus in different ways. This minimises the virus's ability to replicate and multiply, and helps prevent it becoming resistant to treatment.

How do I take Intelence?

This medicine should be taken after a meal, as food increases the absorption of the medicine into the body. If you take the tablets on an empty stomach only half the amount of medicine is absorbed.

Intelence tablets should be taken twice a day, after a meal. The tablets should be swallowed whole with a drink. If you have trouble swallowing the tablets whole they can be dispersed in water before taking - make sure you follow the instructions in the information leaflet provided with the tablets.

Try to take the tablets at the same times each day. If you forget to take a dose at your usual time and it is less than six hours late when you remember, you should take the missed dose as soon as possible after a meal. Then take your next dose as usual when it is due. If you are more than six hours late taking a dose you should skip the missed dose and just take your next dose as usual when it is due. Do not take a double dose to make up for a missed dose.

You must keep taking this medicine regularly every day unless your doctor tells you to stop.

Important information about Intelence

The HIV virus is very good at becoming resistant to anti-HIV medicines. For this reason it is very important that you carefully follow your doctor's instructions for taking your anti-HIV medicines, in order to maintain effective levels of the medicines in your blood. If the blood levels of the medicines drop, the virus will be given more chance to replicate and develop resistance to the drugs. Skipping even a few doses increases the risk of treatment failure, so you should try to ensure that you take all your doses at the correct time, and that you visit your doctor for repeat prescriptions before you run out of medicine.

A rash is the most common side effect associated with this medicine. It is most likely to occur in the second week after starting treatment and is more likely in women. The rash is usually mild to moderate and usually gets better on its own in a couple of weeks without stopping treatment. However, on rare occasions the rash may get worse and serious blistering or peeling skin reactions or hypersensitivity reactions may occur. For this reason, you should consult your doctor straight away if you get a skin rash that is getting worse, or if you also get symptoms such as sores or ulcers inside your mouth, blistering, fever, aching muscles or joints, eye inflammation, or feeling generally unwell while you are taking this medicine, because you may need to stop treatment.

Treatment of HIV infection with anti-HIV medicines such as this one has been shown to reduce the risk of transmitting the virus to other people through sexual contact. However, it does not remove this risk entirely. You should continue to use condoms to prevent transmitting the virus to your sexual partner.

People taking antiretroviral medicines may gain weight and may also experience increases in the levels of sugar and fats in their blood. However these changes are in part linked to the improvement in control over your HIV and your lifestyle. Your doctor may want to monitor the levels of lipids (eg cholesterol) and sugar (glucose) in your blood, and may prescribe additional medicines for any lipid disorders that occur during treatment with this medicine.

Some people being treated with combination antiretroviral therapy may develop a bone condition called osteonecrosis. This condition is caused by loss of blood supply to a bone, causing death of the bone tissue. The risk of the condition is thought to be increased by corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, advanced HIV disease and long-term use of antiretroviral medicines. If you notice any joint stiffness, aches and pains (especially of the hip, knee and shoulder) or difficulty in movement while taking antiretrovirals, you should tell your doctor so this can be investigated.

If you have advanced HIV and a history of opportunistic infections such as pneumocystis carinii pneumonia (PCP) or cytomegalovirus (CMV), you may experience signs and symptoms of inflammation from previous infections soon after you start combination anti-HIV treatment. It is believed that these symptoms are due to an improvement in the body's immune response, which enables the body to fight infections that may have been present with no obvious symptoms. You should tell your doctor immediately if you experience any signs or symptoms of infection, such as inflammation or high temperature, after starting treatment with this medicine.

You should store your Intelence tablets in the container in which they were originally dispensed and not transfer them to another container. This is because the original container contains a desiccant that stops the tablets absorbing moisture. Do not remove the desiccant pouches and keep the bottle tightly closed.

Intelence should be used with caution in

People with a history of severe skin reactions to other non-nucleoside reverse transcriptase inhibitors, eg efavirenz or nevirapine.

Intelence should not be used in

Children aged under six years or weighing less than 16kg.

People with severely decreased liver function.

Intelence 25mg and 100mg tablets contain lactose and are unsuitable for people with the rare hereditary disorders of galactose intolerance, Lapp lactase deficiency or glucose/galactose malabsorption syndrome.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

The safety of this medicine for use during pregnancy has not yet been fully established. It should only be used during pregnancy if considered essential by your doctor. Other anti-HIV medicines that have a more established safety profile in pregnancy can be used to help prevent the transmission of the virus to the developing baby and may be a preferable treatment option for pregnant women. It is important to get medical advice from your doctor straight away if you think you could be pregnant while taking this medicine.

In the UK it is currently recommended that HIV positive women should not breastfeed their infants, regardless of their treatment, in order to avoid transmitting the virus to the baby in the breast milk. Mothers are advised to feed their babies with formula from birth. You should discuss this with your doctor.

Possible side effects of Intelence

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

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Very common (affect more than 1 in 10 people)

Rash (see warning section above).

Common (affect between 1 in 10 and 1 in 100 people)

Decrease in the number of red blood cells or platelets in the blood (anaemia or thrombocytopenia).

Disorder of the peripheral nerves causing weakness, tingling and numbness (peripheral neuropathy). Consult your doctor if you experience these types of symptoms.

Headache.

Disturbances of the gut such as diarrhoea, heartburn, vomiting, nausea, abdominal pain and wind.

Uncommon (affect between 1 in 100 and 1 in 1000 people)

Blurred vision.

Dizziness.

Loss of appetite.

Dry mouth or inflammation of the mouth.

Sleepiness.

Sleep disturbances, such as abnormal dreams, nightmares.

Confusion or memory loss.

Liver problems such as hepatitis. Symptoms that may suggest a liver problem include persistent nausea and vomiting, abdominal pain, or the development of jaundice (a yellow colouring to the skin and the whites of the eyes). Consult your doctor if you experience any of these symptoms.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

If you think you have experienced a side effect from a medicine or vaccine you should check the patient information leaflet. This lists the known side effects and what to do if you get them. You can also get advice from your doctor, nurse or pharmacist. If they think it's necessary they'll report it for you.

How can Intelence affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.

Etravirine is not recommended for use in combination with the following anti-HIV medicines:

efavirenz

indinavir

nelfinavir

nevirapine

rilpivirine

tipranavir/ritonavir.

The following medicines may decrease the amount of etravirine in the blood. This could make etravirine less effective against HIV and could also allow the virus to become resistant to the medicine:

boceprevir (etravirine may also decrease the blood level of boceprevir)

Etravirine may decrease the blood levels of the following medicines and could therefore make these medicines less effective. Your doctor may need to do extra monitoring or adjust your doses if you are taking any of these medicines with etravirine:

statin medicines used to treat high cholesterol levels, such as atorvastatin, lovastatin or simvastatin. If you are taking a statin in combination with etravirine, your cholesterol levels should be regularly monitored to make sure the statin is still producing an effect. Your doctor may need to adjust your statin dose. Pravastatin is not expected to be affected by etravirine.

Etravirine may increase the blood level of digoxin. If etravirine is used in combination with digoxin it is recommended that the blood level of digoxin is monitored.

Etravirine may increase the blood level of diazepam. As this could increase the risk of diazepam side effects, alternative medicines to diazepam are recommended.

Etravirine may increase the blood level of the anti-blood-clotting (anticoagulant) medicine warfarin. If you are taking warfarin with this medicine, your blood-clotting time (INR) should be monitored.

Etravirine may make the antibiotic clarithromycin less effective at treating infections caused by Mycobacterium avium complex (MAC). It is recommended that other antibiotics are used to treat this infection in people taking etravirine.

The weight loss medicine orlistat has been reported to reduce the absorption of anti-HIV medicines from the gut and could make them less effective.

Other medicines containing etravirine

There are currently no other medicines available in the UK that contain etravirine as the active ingredient.

Further reading

For background information about our medicine factsheets, including the references used to produce them, click here.

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